November/December 2020 EuroLabNews

6. Updates on EFLM publications

6.1. European Biological Variation Study (EuBIVAS): within- and between-subject biological variation estimates for serum biointact parathyroid hormone based on weekly samplings from 91 healthy participants

Michela BottaniGiuseppe BanfiElena GuerraMassimo LocatelliAasne K. AarsandAbdurrahman CoşkunJorge Díaz-GarzónPilar Fernandez-CalleSverre SandbergFerruccio CeriottiElisabet González-LaoMargarita SimonAnna Carobene, and on behalf of the European Federation of Clinical Chemistry and Laboratory Medicine Working Group on Biological Variation

Correspondence to: Dr. Michela Bottani,
Ann Transl Med. 2020 Jul; 8(14): 855. doi: 10.21037/atm-19-4498, PMID: 32793699

Reported by Aleksei Tikhonov, member-young scientist of EFLM WG-Promotion & Publications
The European Biological Variation Study (EuBIVAS) was created by the EFLM Working Group on Biological Variation to establish high-quality biological variation (BV) estimates for clinically important measurands. In this study, the aim was to deliver reliable BV estimates for the biointact parathyroid hormone (PTH 1-84).
The within-subject BV [CVI (95% CI)] estimates were significantly different between men and women [13.0% (12.1–14.2%) and 15.2% (14.3–16.3%), respectively], while the between-subject estimates [CVG (95% CI)] were similar (men: 26.8% (21.4–35.1%), pre-menopausal women: 27.8% (22.7–36.1%)], allowing for delivery of updated analytical performance specifications and reference change values.
The EuBIVAS CVI estimates were lower than those delivered by previously published papers on biointact PTH, possibly related to different statistical approaches and to the strict control of the fasting status. These EuBIVAS BV estimates, together with a suitable interpretation of the PTH 1-84 concentration changes, represent a key tool in medical practice for a correct diagnosis and monitoring of bone turnover and parathyroid glands pathologies, for patient management, for creating standardized protocols for the pre-analytical, analytical, and post-analytical stages of PTH evaluation, and for giving information about the analytical quality of the method used for PTH 1-84 evaluation.